a-PRP Intrauterine Instillation in Women With Thin Endometrium (PRP(a-PRP))

Effect of Autologous Platelet Rich Plasma(a-PRP) Intrauterine Instillation in Infertile Women With Thin Endometrium in Frozen-thawed Embryo Transfer Cycle: a Randomized Controlled Study

This study sought to compare the endometrial thickness among infertile women with a history of thin endometrium together with previous cancellation from IVF/ICSI inspection of intrauterine instillation of autologous-PRP or no treatment before embryo transfer in the frozen-thaw cycles.

Study Overview

• Status: Recruiting
• Conditions: Thin Endometrium
• Intervention / Treatment: Other: Standard treatment; Procedure: PRP

Detailed Description

At present, infertility is a major problem in Thailand. As a result, the Ministry of Public Health has to push the guidelines for using reproductive technology to play a role in increasing the population in the country. The most well-known use of reproductive technology is In vitro fertilization (IVF) has a success rate of approximately 35-40%. There are many factors affecting the success of pregnancy, one of which is the thickness of the uterine cavity.

An endometrial thickness of less than 7 mm in the middle of the menstrual cycle is called endometrial lining. Thin endometrium, which can affect pregnancy Both the rate of embryo implantation pregnancy rate and miscarriage rates In the process of IVF In practice, the appropriate and popular thickness of the uterine cavity for embryo transfer is based on a thickness greater than equal to 7 mm. This is because many studies have found that the thickness of the uterine cavity At 8 mm, this can significantly increase pregnancy rates.

Platelet Rich Plasma (PRP) is another new treatment approach. There is information and research results that show that PRP can increase the thickness of the uterine cavity. and found to help increase blood flowing to the area The uterine wall in infertile women who have a thin uterine cavity. According to a study by Chang et al., in 2015, PRP was used to increase the thickness of the uterine cavity. Found that it can increase the thickness of the uterine cavity. It also tends to increase the pregnancy rate. This is likely caused by Helping increase the number of cells cell regeneration and repair of worn out parts of body cells Through the main mechanism of PRP is adding substances that stimulate cell growth (Growth factors) and proteins that are signals between cells (Cytokines). Someone has studied and compared the levels of substances that stimulate cell growth in PRP. Compared with lymph (plasma), it was found that the levels of cell growth stimulants in PRP were 2.4-2.8 times higher than those in lymph, with statistical significance.

Moreover, the process of preparing PRP is not complicated and the prepared ingredients do not cause any harmful side effects to the body. Therefore, it can be seen from various sectors and various studies that PRP has been used to accelerate growth, such as treating hair loss or baldness. Reducing inflammation or pain in various joints Or even use it to restore beauty, nourish the skin, etc.

In this study The authors therefore attempt to demonstrate the benefits of PRP that may promote endometrial thickening in women with endometrial hyperplasia in order to achieve appropriate endometrial thickness. Received embryo transfer in the next embryo freezing cycle. In addition, in Thailand there has never been a study of increasing the thickness of the uterine cavity with PRP injections before. Therefore, the creators expect that this method may be a method that can increase the implantation rate. Embryo or clinical pregnancy rate Including reducing the rate of embryo implantation cancellations to reduce anxiety for infertile couples in Thailand.

• Study Type: Interventional
• Enrollment (Estimated): 36
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Sootthinan Pothisan; Phone Number: 0894600852; Email: sootthinan.pot@gmail.com
• Study Contact Backup: Name: Nichamon Parkpinyo; Phone Number: 0867632251; Email: ni_nichamon@hotmail.com

Study Locations

• Thailand
  • Bangkok
    • Bangkok Noi, Bangkok, Thailand, 10700
      • Recruiting
      • Siriraj Hospital
      • Contact: Sootthinan Pothisan; Phone Number: 0894600852; Email: sootthinan.pot@gmail.com
      • Contact: Nichamon Parkpinyo; Phone Number: 0867632251; Email: ni_nichamon@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients who will undergo frozen embryo transfer (Frozen-thawed cycle)
• Age above 18 years
• Thai nationality
• Have a history of cycle cancellation due to a thin endometrium <7 mm. after standard hormonal treatmetn

Exclusion Criteria:

• medical conditions eg. Platelet dysfunction , vWD
• thrombocytopenia <100,000 cell/mm3
• Receive antiplatelet therapy
• Uterine anomaly, cavity distortion eg submucous myoma uteri, uterine synergia, endometrial polyp

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: aPRP 1; a-PRP intrauterine instillation on Menstruation Cycle Day 8 during frozen thaw cycle procedure	Procedure: PRP; a-PRP intrauterine instillation before frozen-thawed embryo transfer cycle
Experimental: aPRP 2; a-PRP intrauterine instillation on Menstruation Cycle Day 8 and Day 10 during frozen thaw cycle procedure	Procedure: PRP; a-PRP intrauterine instillation before frozen-thawed embryo transfer cycle
Experimental: Controlled; Standard treatment of frozen thaw cycle	Other: Standard treatment; Standard treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endometrial thickness	compare endometrial thickness among 3 group	day 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
endometrial thickness difference between day 8 and day 12	compare endometrial thickness day 8 and day 12	between day 8 and day 12
clinical pregnancy rate	seen FHB at 12 weeks	12 weeks
chemical pregnancy rate	hcg > 25 u	2 weeks after transfer
miscarriage rate	abortion < 12 weeks	up to 12 weeks
cancellation rate	cancel cycle from thin endometrium < 7 mm	day 14

Collaborators and Investigators

• Sponsor: Mahidol University
• Investigators: Principal Investigator: Sootthinan Pothisan, Mahidol University

Study record dates

Study Major Dates

• Study Start (Actual): January 21, 2024
• Primary Completion (Estimated): January 31, 2025
• Study Completion (Estimated): May 31, 2025

Study Registration Dates

• First Submitted: January 23, 2024
• First Submitted That Met QC Criteria: January 30, 2024
• First Posted (Actual): January 31, 2024

Study Record Updates

• Last Update Posted (Actual): January 31, 2024
• Last Update Submitted That Met QC Criteria: January 30, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: PRP, Platelet-rich plasma, IVF/ICSI, Frozen Thaw cycle
• Other Study ID Numbers: 853/2566(IRB4); WHO (Other Identifier: U1111-1303-0085)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No